Zimmer Biomet recalls specific hip fracture nail models due to set screw not advancing or reversing properly. Affected units may not function correctly during surgery.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling certain hip fracture nail models because the set screw cannot properly advance or reverse. This could lead to improper fixation during surgery, potentially causing complications for patients.
The set screw in the nail fails to move forward or backward from its starting position. This could prevent the nail from securely fixing the bone fragments during surgery, potentially leading to complications.
Surgical teams using the specific model of hip fracture nail (130°, 13 mm x 320 mm) with item number 814613320 are affected. Patients undergoing hip fracture surgery with this model are at risk of improper fixation.
Check for the model name 'Affixus Hip Fracture Nail Left 130° 13 mm x 320 mm' and item number 814613320. The product was sold in specific quantities identified by the numbers 245390 and 287180.
Verify the model name and item number on the product packaging.
The set screw cannot advance or reverse from the original position in the nail, which may prevent proper bone fixation during surgery.
Look for the model name 'Affixus Hip Fracture Nail Left 130° 13 mm x 320 mm' and item number 814613320.
The recall record does not specify a remedy, so contact Zimmer Biomet directly for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3166-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3166-2018 from Zimmer Biomet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
